Clinical trial • Phase III • Immunology

NIPOCALIMAB for Sjögren's disease | Sjögren's syndrome

Phase III trial of NIPOCALIMAB for Sjögren's disease | Sjögren's syndrome.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Sjögren's disease | Sjögren's syndrome
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
19-05-2025
First CTIS Authorization Date
05-06-2025

Trial design

Randomised, placebo subcutaneous without nipocalimab (placebo comparator arm). dose and schedule not specified in the available record.-controlled Phase III trial in Austria, Italy, Bulgaria and others.

Randomised
Yes
Comparator
Placebo subcutaneous without Nipocalimab (placebo comparator arm). Dose and schedule not specified in the available record.
Target Sample Size
507
Trial Duration For Participant
336

Eligibility

Recruits 507 The record indicates isVulnerablePopulationSelected = true and subject information and informed consent forms (SIS and ICF) are provided (country-specific versions listed). Additional ICF documents are present for 'Pregnant Partner' and for 'Child exposed to IP' (country-specific files listed), indicating special information materials for these situations. Consent is obtained via the provided subject information and informed consent forms; country and language-specific ICFs are available (examples in English, German, Italian, Spanish, French, Bulgarian, Hungarian, Portuguese, Romanian, Polish and others as listed in the documents). No explicit description of assent procedures for minors is provided in the available text..

Pregnancy Exclusion
Participants of childbearing potential must have a negative highly sensitive serum (beta-hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0 prior to randomization.
Vulnerable Population
The record indicates isVulnerablePopulationSelected = true and subject information and informed consent forms (SIS and ICF) are provided (country-specific versions listed). Additional ICF documents are present for 'Pregnant Partner' and for 'Child exposed to IP' (country-specific files listed), indicating special information materials for these situations. Consent is obtained via the provided subject information and informed consent forms; country and language-specific ICFs are available (examples in English, German, Italian, Spanish, French, Bulgarian, Hungarian, Portuguese, Romanian, Polish and others as listed in the documents). No explicit description of assent procedures for minors is provided in the available text.

Inclusion criteria

  • {"criterion_text":"- 1. Medically stable on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG) and clinical laboratory tests performed at screening.\n- 2. Meets criteria for diagnosis of SjD by the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria.\n- 3. Seropositive for antibodies to Ro/SSA at screening.\n- 4. Total ClinESSDAI score greater than or equal to (>=) 5 at screening.\n- 5. Participants of childbearing potential must have a negative highly sensitive serum (beta-hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0 prior to randomization."}

Exclusion criteria

  • {"criterion_text":"- 1. Has a history of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder or clinically significant abnormalities in screening laboratory.\n- 2. Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients or excipients used in the placebo formulation.\n- 3. Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her SjD or has a family history of congenital or hereditary immunodeficiency.\n- 4. Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins (for example [e.g.], monoclonal antibodies, intravenous immunoglobulin).\n- 5. Has any unstable or progressive manifestation of SjD that is likely to warrant escalation in therapy beyond permitted background medications."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from Baseline in Clinical European League Against Rheumatism Sjogren’s Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48.","definition_or_measurement_approach":"Change from baseline measured by the ClinESSDAI score at Week 48."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
507
Recruitment Window Months
59
Consent Approach
Informed consent is obtained using subject information sheets and informed consent forms (SIS and ICF). Country-specific and language-specific ICF documents are provided (examples include English, German, Italian, Spanish, French, Bulgarian, Hungarian, Portuguese, Romanian, Polish, Dutch, Norwegian and Slovak versions listed). Separate/additional ICF documents are provided for topics such as pregnancy/pregnant partner, optional genetic samples, withdrawal, and child exposed to IP. The ICFs and SIS materials are the mechanism for obtaining consent from adult participants; no explicit textual detail on assent for minors is provided in the available record.

Methods

  • Country-specific recruitment arrangements documents submitted (K1 files) are present for multiple countries (examples: Austria, Italy, Bulgaria, Portugal, Romania, Denmark, Spain, France, Germany, Poland, Hungary, Netherlands, Norway, Czechia, Slovakia).
  • Digital advertising and online recruitment (document titles include 'Digital Ad', 'Digital Ad visuals', 'Search Ads', 'Landing Page Copy screenshot', 'ClinLife digital campaign', 'ClinLife Portal' — e.g. Poland and other country-specific K2 materials).
  • Printed materials and site-based materials: recruitment brochures, recruitment posters (document titles 'Recruitment Poster', 'Recruitment Brochure').
  • Clinician-to-patient outreach: doctor-to-patient emails (document titles 'Dr to Patient Email' / 'Doctor to Patient Email').
  • Pre-screening and call-center scripts: 'Master WS Script', 'Master Pre-screening Script', 'Pre-screening Script' (Poland and other country materials listed).
  • Other channels mentioned in materials: patient messaging, adverts for subject recruitment and adverts for subject recruitment visuals (country-specific K2 files).

Geography

Total Number Of Sites
109
Total Number Of Participants
309

Austria

Earliest CTIS Part Ii Submission Date
16-05-2025
Latest Decision Or Authorization Date
05-06-2025
Processing Time Days
20
Number Of Sites
4
Number Of Participants
26

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Internal Medicine III, Division of Rheumatology
Principal Investigator Name
Paul Studenic
Principal Investigator Email
paul.studenic@meduniwien.ac.at
Contact Person Name
Paul Studenic
Contact Person Email
paul.studenic@meduniwien.ac.at
Site Name
Landesklinikum Stockerau
Department Name
2. Med. Department, with main focus on Rheumatology
Principal Investigator Name
Judith Sautner
Principal Investigator Email
judith.sautner@stockerau.lknoe.at
Contact Person Name
Judith Sautner
Site Name
SCRI CCCIT Ges.m.b.H.
Department Name
III Med
Principal Investigator Name
Ildiko Toth
Principal Investigator Email
i.toth@salk.at
Contact Person Name
Ildiko Toth
Contact Person Email
i.toth@salk.at
Site Name
Medical University Of Graz
Department Name
Division of Rheumatology and Immunology
Principal Investigator Name
Martin Stradner
Principal Investigator Email
martin.stradner@medunigraz.at
Contact Person Name
Martin Stradner
Contact Person Email
martin.stradner@medunigraz.at

Italy

Earliest CTIS Part Ii Submission Date
16-05-2025
Latest Decision Or Authorization Date
19-06-2025
Processing Time Days
34
Number Of Sites
11
Number Of Participants
18

Sites

Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
Clinica Reumatologica
Principal Investigator Name
Giuliana Guggino
Principal Investigator Email
giuliana.guggino@unipa.it
Contact Person Name
Giuliana Guggino
Contact Person Email
giuliana.guggino@unipa.it
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
S.O.C. Clinica di Reumatologia - ASUFC
Principal Investigator Name
Luca Quartuccio
Principal Investigator Email
luca.quartuccio@asufc.sanita.fvg.it
Contact Person Name
Luca Quartuccio
Site Name
Hospital Santa Maria Della Misericordia
Department Name
Medicine and Surgery
Principal Investigator Name
Elena Bartoloni Bocci
Principal Investigator Email
elena.bartolonibocci@unipg.it
Contact Person Name
Elena Bartoloni Bocci
Contact Person Email
elena.bartolonibocci@unipg.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Clinical Unit of Immunology, Rheumatology, Allergy and Rare diseases
Principal Investigator Name
Lorenzo Dagna
Principal Investigator Email
dagna.lorenzo@hsr.it
Contact Person Name
Lorenzo Dagna
Contact Person Email
dagna.lorenzo@hsr.it
Site Name
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
Department Name
U.O.C. Reumatologia Clinica
Principal Investigator Name
Nicoletta Del Papa
Principal Investigator Email
nicoletta.delpapa@asst-pini-cto.it
Contact Person Name
Nicoletta Del Papa
Site Name
Humanitas Mirasole S.p.A.
Department Name
U.O.C. Rheumatology
Principal Investigator Name
Serena Colafrancesco
Principal Investigator Email
serena.colafrancesco@humanitasresearch.it
Contact Person Name
Serena Colafrancesco
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Scienze Cliniche Internistiche Anestesiologiche Cardiovascolari -UOC Reumatologia
Principal Investigator Name
Fabrizio Conti
Principal Investigator Email
fabrizio.conti@uniroma1.it
Contact Person Name
Fabrizio Conti
Contact Person Email
fabrizio.conti@uniroma1.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
U.O.C. Rheumatology
Principal Investigator Name
Maria Antonietta D’gostino
Contact Person Name
Maria Antonietta D’gostino
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
S.C. Reumatologia
Principal Investigator Name
Dilia Giuggioli
Principal Investigator Email
dilia.giuggioli@unimore.it
Contact Person Name
Dilia Giuggioli
Contact Person Email
dilia.giuggioli@unimore.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Medicina Clinica e Sperimentale - U.O. di Reumatologia
Principal Investigator Name
Chiara Baldini
Principal Investigator Email
chiara.baldini74@gmail.com
Contact Person Name
Chiara Baldini
Contact Person Email
chiara.baldini74@gmail.com
Site Name
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Department Name
U.O.C di Immunoreumatologia
Principal Investigator Name
Roberto Giacomelli
Principal Investigator Email
r.giacomelli@policlinicocampus.it
Contact Person Name
Roberto Giacomelli

Bulgaria

Earliest CTIS Part Ii Submission Date
16-05-2025
Latest Decision Or Authorization Date
17-06-2025
Processing Time Days
32
Number Of Sites
9
Number Of Participants
26

Sites

Site Name
Diagnostic-Consultative Center Alexandrovska EOOD
Department Name
Not Applicable
Principal Investigator Name
Delina Ivanova
Principal Investigator Email
delina_ivanov@abv.bg
Contact Person Name
Delina Ivanova
Contact Person Email
delina_ivanov@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Department Name
Rheumatology Clinic
Principal Investigator Name
Anastas Batalov
Principal Investigator Email
abatalov@hotmail.com
Contact Person Name
Anastas Batalov
Contact Person Email
abatalov@hotmail.com
Site Name
Diagnostic Consultative Center Equita OOD
Department Name
Not Applicable
Principal Investigator Name
Daniela Kamburova
Principal Investigator Email
dkamburova5@gmail.com
Contact Person Name
Daniela Kamburova
Contact Person Email
dkamburova5@gmail.com
Site Name
Medical Center Teodora EOOD
Department Name
Not Applicable
Principal Investigator Name
Margarita Velkova
Principal Investigator Email
dr_margarita_velkova@mail.bg
Contact Person Name
Margarita Velkova
Contact Person Email
dr_margarita_velkova@mail.bg
Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
Clinic of Rheumatology
Principal Investigator Name
Rasho Rashkov
Principal Investigator Email
proff_rashkov@yahoo.com
Contact Person Name
Rasho Rashkov
Contact Person Email
proff_rashkov@yahoo.com
Site Name
Mbal Lyulin EAD
Department Name
Rheumatology Department
Principal Investigator Name
Aneliya Radikova
Principal Investigator Email
a.radikova@mail.bg
Contact Person Name
Aneliya Radikova
Contact Person Email
a.radikova@mail.bg
Site Name
Military Medical Academy
Department Name
Rheumatology Department
Principal Investigator Name
Boycho Oparanov
Principal Investigator Email
oparanov@abv.bg
Contact Person Name
Boycho Oparanov
Contact Person Email
oparanov@abv.bg
Site Name
Medical Center Artmed Ltd.
Department Name
Not Applicable
Principal Investigator Name
Mariela Geneva-Popova
Principal Investigator Email
genevapopova@yahoo.com
Contact Person Name
Mariela Geneva-Popova
Contact Person Email
genevapopova@yahoo.com
Site Name
MBAL Sveta Marina EAD
Department Name
Rheumatology Clinic
Principal Investigator Name
Tsvetoslav Georgiev
Principal Investigator Email
ts.a.georgiev@gmail.com
Contact Person Name
Tsvetoslav Georgiev
Contact Person Email
ts.a.georgiev@gmail.com

Portugal

Earliest CTIS Part Ii Submission Date
16-05-2025
Latest Decision Or Authorization Date
11-06-2025
Processing Time Days
26
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Department Name
Rheumatology
Principal Investigator Name
Fernando Pimentel dos Santos
Principal Investigator Email
pimentel.santos@gmail.com
Contact Person Name
Fernando Pimentel dos Santos
Contact Person Email
pimentel.santos@gmail.com
Site Name
Instituto Portugues De Reumatologia
Department Name
Rheumatology
Principal Investigator Name
Filipe Barcelos
Principal Investigator Email
fduartebarcelos@gmail.com
Contact Person Name
Filipe Barcelos
Contact Person Email
fduartebarcelos@gmail.com
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Rheumatology
Principal Investigator Name
Nikita Khmelinskii
Principal Investigator Email
nkhmelinskii@gmail.com
Contact Person Name
Nikita Khmelinskii
Contact Person Email
nkhmelinskii@gmail.com
Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Rheumatology
Principal Investigator Name
Tiago Meirinhos
Principal Investigator Email
tiago.meirinhos@ulsge.min-saude.pt
Contact Person Name
Tiago Meirinhos

Romania

Earliest CTIS Part Ii Submission Date
12-06-2025
Latest Decision Or Authorization Date
30-06-2025
Processing Time Days
18
Number Of Sites
7
Number Of Participants
16

Sites

Site Name
Selfmed Clinique S.R.L.
Principal Investigator Name
Viorica Crisan
Principal Investigator Email
viocrisan2002@yahoo.com
Contact Person Name
Viorica Crisan
Contact Person Email
viocrisan2002@yahoo.com
Site Name
Spitalul Clinic Judetean De Urgenta Cluj
Department Name
Rheumatology
Principal Investigator Name
Simona Rednic
Principal Investigator Email
srednic@umfcluj.ro
Contact Person Name
Simona Rednic
Contact Person Email
srednic@umfcluj.ro
Site Name
Medisof Diagnostic S.R.L.
Department Name
Rheumatology
Principal Investigator Name
Anca Emanuela Musetescu
Principal Investigator Email
anca_musetescu@yahoo.com
Contact Person Name
Anca Emanuela Musetescu
Contact Person Email
anca_musetescu@yahoo.com
Site Name
Saint Maria Hospital
Department Name
Rheumatology
Principal Investigator Name
Florian Berghea
Principal Investigator Email
berghea1@gmail.com
Contact Person Name
Florian Berghea
Contact Person Email
berghea1@gmail.com
Site Name
Policlinica CCBR S.R.L.
Principal Investigator Name
Sorica Mustatea
Principal Investigator Email
sorica.mustatea@clinicaccbr.com
Contact Person Name
Sorica Mustatea
Site Name
Hiperdia S.A.
Principal Investigator Name
Camelia Georgeta Badea
Principal Investigator Email
camelia.badea@affidea.com
Contact Person Name
Camelia Georgeta Badea
Contact Person Email
camelia.badea@affidea.com
Site Name
Spitalul Clinic Colentina Bucuresti
Department Name
IIIrd Internal Medicine
Principal Investigator Name
Razvan Adrian Ionescu
Principal Investigator Email
tane67@gmail.com
Contact Person Name
Razvan Adrian Ionescu
Contact Person Email
tane67@gmail.com

Denmark

Earliest CTIS Part Ii Submission Date
16-05-2025
Latest Decision Or Authorization Date
11-06-2025
Processing Time Days
26
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Sygehus Lillebaelt Vejle Sygehus
Department Name
Reumatologisk Afdeling-Medicinsk Afdeling
Principal Investigator Name
Tine Lottenburger
Principal Investigator Email
tine.lottenburger@rsyd.dk
Contact Person Name
Tine Lottenburger
Contact Person Email
tine.lottenburger@rsyd.dk
Site Name
Rigshospitalet
Department Name
Reumatology Department
Principal Investigator Name
Soren Jacobsen
Principal Investigator Email
soeren.jacobsen.01@regionh.dk
Contact Person Name
Soren Jacobsen
Contact Person Email
soeren.jacobsen.01@regionh.dk
Site Name
Aarhus University Hospital
Department Name
Reumatology Department
Principal Investigator Name
Anne Troldborg
Principal Investigator Email
annetrol@rm.dk
Contact Person Name
Anne Troldborg
Contact Person Email
annetrol@rm.dk
Site Name
Region Sjaelland
Department Name
Reumatology Department
Principal Investigator Name
Ada Colic
Principal Investigator Email
adco@regionsjaelland.dk
Contact Person Name
Ada Colic
Contact Person Email
adco@regionsjaelland.dk

Spain

Earliest CTIS Part Ii Submission Date
16-05-2025
Latest Decision Or Authorization Date
06-06-2025
Processing Time Days
21
Number Of Sites
8
Number Of Participants
21

Sites

Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Rheumatology
Principal Investigator Name
Hector Corominas Macias
Principal Investigator Email
hcorominas@santpau.cat
Contact Person Name
Hector Corominas Macias
Contact Person Email
hcorominas@santpau.cat
Site Name
Sanitas S.A. De Hospitales
Department Name
Internal Medicine
Principal Investigator Name
Pilar Brito Zeron
Principal Investigator Email
mpbrito@sanitas.es
Contact Person Name
Pilar Brito Zeron
Contact Person Email
mpbrito@sanitas.es
Site Name
Hospital Universitario Juan Ramon Jimenez
Department Name
Rheumatology
Principal Investigator Name
Marta Llanes Gomez
Principal Investigator Email
martam.llanes.sspa@juntadeandalucia.es
Contact Person Name
Marta Llanes Gomez
Site Name
Hospital Universitari Vall D Hebron
Department Name
Internal Medicine
Principal Investigator Name
Roser Solans i Laque
Principal Investigator Email
mariaroser.solans@vallhebron.cat
Contact Person Name
Roser Solans i Laque
Site Name
Hospital Quironsalud Infanta Luisa
Department Name
Rheumatology
Principal Investigator Name
Juan Miguel Sanchez Burson
Principal Investigator Email
reujsb@gmail.com
Contact Person Name
Juan Miguel Sanchez Burson
Contact Person Email
reujsb@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Rheumatology
Principal Investigator Name
Ricardo Blanco Alonso
Principal Investigator Email
rblanco@humv.es
Contact Person Name
Ricardo Blanco Alonso
Contact Person Email
rblanco@humv.es
Site Name
Hospital Universitario De Navarra
Department Name
Rheumatology
Principal Investigator Name
Ruben Arnaez Solis
Principal Investigator Email
ruben.arnaez.solis@navarra.es
Contact Person Name
Ruben Arnaez Solis
Contact Person Email
ruben.arnaez.solis@navarra.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Rheumatology
Principal Investigator Name
Sheila Melchor Diaz
Principal Investigator Email
sheila.melchor@salud.madrid.org
Contact Person Name
Sheila Melchor Diaz

France

Earliest CTIS Part Ii Submission Date
04-07-2025
Latest Decision Or Authorization Date
07-07-2025
Processing Time Days
3
Number Of Sites
9
Number Of Participants
17

Sites

Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Internal Medicine and Clinical Immunology
Principal Investigator Name
Noemie GENSOUS
Principal Investigator Email
noemie.gensous@chu-bordeaux.fr
Contact Person Name
Noemie GENSOUS
Contact Person Email
noemie.gensous@chu-bordeaux.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Rheumatology Department
Principal Investigator Name
Raphaelle SEROR
Principal Investigator Email
Raphaele.seror@aphp.fr
Contact Person Name
Raphaelle SEROR
Contact Person Email
Raphaele.seror@aphp.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Internal Medicine and Clinical Immunology
Principal Investigator Name
Bernard BONNOTTE
Principal Investigator Email
bernard.bonnotte@chu-dijon.fr
Contact Person Name
Bernard BONNOTTE
Contact Person Email
bernard.bonnotte@chu-dijon.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Rheumatology Department
Principal Investigator Name
Damien SENE
Principal Investigator Email
damien.sene@aphp.fr
Contact Person Name
Damien SENE
Contact Person Email
damien.sene@aphp.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Rheumatology Department
Principal Investigator Name
Martin KILLIAN
Principal Investigator Email
martin.killian@chu-st-etienne.fr
Contact Person Name
Martin KILLIAN
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Rheumatology Department
Principal Investigator Name
Jacques-Eric GOTTENBERG
Principal Investigator Email
jacques-eric.gottenberg@chru-strasbourg.fr
Contact Person Name
Jacques-Eric GOTTENBERG
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Rheumatology Department
Principal Investigator Name
Jacques MOREL
Principal Investigator Email
j-morel@chu-montpellier.fr
Contact Person Name
Jacques MOREL
Contact Person Email
j-morel@chu-montpellier.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Rheumatology Department
Principal Investigator Name
Valerie DEVAUCHELLE-PENSEC
Principal Investigator Email
valerie.devauchelle-pensec@chu-brest.fr
Contact Person Name
Valerie DEVAUCHELLE-PENSEC
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Rheumatology Department
Principal Investigator Name
Eric HACHULLA
Principal Investigator Email
Eric.hachulla@chru-lille.fr
Contact Person Name
Eric HACHULLA
Contact Person Email
Eric.hachulla@chru-lille.fr

Germany

Earliest CTIS Part Ii Submission Date
16-05-2025
Latest Decision Or Authorization Date
13-06-2025
Processing Time Days
28
Number Of Sites
12
Number Of Participants
45

Sites

Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Rheumatologie and Immunology
Principal Investigator Name
Ricardo Grieshaber-Bouyer
Principal Investigator Email
ricardo.grieshaber@fau.de
Contact Person Name
Ricardo Grieshaber-Bouyer
Contact Person Email
ricardo.grieshaber@fau.de
Site Name
Krankenhaus Porz Am Rhein gGmbH
Department Name
Klinik für Rheumatologie
Principal Investigator Name
Johannes Strunk
Principal Investigator Email
j.strunk@khporz.de
Contact Person Name
Johannes Strunk
Contact Person Email
j.strunk@khporz.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Medical Department III, Rheumatology and Immunology
Principal Investigator Name
Marc Schmalzing
Principal Investigator Email
schmalzing_m@ukw.de
Contact Person Name
Marc Schmalzing
Contact Person Email
schmalzing_m@ukw.de
Site Name
Studienambulanz Rheumazentrum Ratingen GbR
Principal Investigator Name
Siegfried Wassenberg
Principal Investigator Email
wassenberg@rhzr.de
Contact Person Name
Siegfried Wassenberg
Contact Person Email
wassenberg@rhzr.de
Site Name
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Department Name
Hamburger Rheuma Forschungszentrum II
Principal Investigator Name
Andrea Everding
Principal Investigator Email
Everding@hotmail.de
Contact Person Name
Andrea Everding
Contact Person Email
Everding@hotmail.de
Site Name
Medicover GmbH
Department Name
Medicover Muenchen Ost MVZ
Principal Investigator Name
David Kofler
Principal Investigator Email
david.kofler@medicover.de
Contact Person Name
David Kofler
Contact Person Email
david.kofler@medicover.de
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Rheumatologie & Immunologie
Principal Investigator Name
Torsten Witte
Principal Investigator Email
witte.torsten@mh-hannover.de
Contact Person Name
Torsten Witte
Contact Person Email
witte.torsten@mh-hannover.de
Site Name
Medical Center - University Of Freiburg
Department Name
Department of Rheumatology and clinical Immunology
Principal Investigator Name
Stephanie Finzel
Principal Investigator Email
stephanie.finzel@uniklinik-freiburg.de
Contact Person Name
Stephanie Finzel
Site Name
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Department Name
Rheumazentrum Ruhrgebiet
Principal Investigator Name
Ioana Andreica
Principal Investigator Email
ioana.andreica@elisabethgruppe.de
Contact Person Name
Ioana Andreica
Site Name
LMU Klinikum Muenchen AöR
Department Name
Klinik f. Rheumatologie
Principal Investigator Name
Hendrik Schulze-Koops
Principal Investigator Email
Hendrik.Schulze-Koops@med.uni-muenchen.de
Contact Person Name
Hendrik Schulze-Koops
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Clinic and Polyclinic for Rheumatology and Clinical Immunology
Principal Investigator Name
Martin Fleck
Principal Investigator Email
m.fleck@asklepios.com
Contact Person Name
Martin Fleck
Contact Person Email
m.fleck@asklepios.com
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Medical Department III, Rheumatology
Principal Investigator Name
Anne-Kathrin Tausche-Wunderlich
Contact Person Name
Anne-Kathrin Tausche-Wunderlich

Poland

Earliest CTIS Part Ii Submission Date
16-05-2025
Latest Decision Or Authorization Date
23-06-2025
Processing Time Days
38
Number Of Sites
14
Number Of Participants
60

Sites

Site Name
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
Principal Investigator Name
Magdalena Krajewska-Wlodarczyk
Principal Investigator Email
magdalenakrajewska@etykaosrodek.pl
Contact Person Name
Magdalena Krajewska-Wlodarczyk
Site Name
Futuremeds Sp. z o.o. (Wroclaw)
Department Name
Futuremeds - Wroclaw
Principal Investigator Name
Ewa Krecipro-Nizinska
Principal Investigator Email
ewa.krecipro-nizinska@futuremeds.com
Contact Person Name
Ewa Krecipro-Nizinska
Site Name
Ai Centrum Medyczne Sp. z o.o.
Principal Investigator Name
Anna Rychlewska-Hanczewska
Principal Investigator Email
info@aiklinika.com
Contact Person Name
Anna Rychlewska-Hanczewska
Contact Person Email
info@aiklinika.com
Site Name
Centrum Medyczne Oporow
Principal Investigator Name
Maria Misterska-Skora
Principal Investigator Email
badania@cmoporow.com
Contact Person Name
Maria Misterska-Skora
Contact Person Email
badania@cmoporow.com
Site Name
Malopolskie Badania Kliniczne Sp. z o.o.
Principal Investigator Name
Bogdan Batko
Principal Investigator Email
biuro@mbk.clinic
Contact Person Name
Bogdan Batko
Contact Person Email
biuro@mbk.clinic
Site Name
Medicover Integrated Clinical Services Sp. z o.o. (Bydgoszcz)
Department Name
MICS Centrum Medyczne Bydgoszcz
Principal Investigator Name
Katarzyna Kolossa
Principal Investigator Email
k.kolossa@naszlekarz.pl
Contact Person Name
Katarzyna Kolossa
Contact Person Email
k.kolossa@naszlekarz.pl
Site Name
Futuremeds Sp. z o.o. (Warsaw)
Department Name
Futuremeds - Targowek
Principal Investigator Name
Agnieszka Jurek-Urbanowska
Principal Investigator Email
agnieszka.urbanowska@futuremeds.com
Contact Person Name
Agnieszka Jurek-Urbanowska
Site Name
ETG Lublin Sp. z o.o. (Debica)
Department Name
ETG Debica
Principal Investigator Name
Katarzyna Surmacz
Principal Investigator Email
k.surmacz@etg-network.com
Contact Person Name
Katarzyna Surmacz
Contact Person Email
k.surmacz@etg-network.com
Site Name
ETG Lublin Sp. z o.o. (Lublin)
Department Name
ETG Lublin
Principal Investigator Name
Katarzyna Zelazowska
Principal Investigator Email
k.zelazowska@etg-network.com
Contact Person Name
Katarzyna Zelazowska
Contact Person Email
k.zelazowska@etg-network.com
Site Name
Futuremeds Sp. z o.o. (Cracow)
Department Name
Futuremeds - Krakow
Principal Investigator Name
Weronika Kleczynska-Szpakiewicz
Principal Investigator Email
weronika.szpakiewicz@futuremeds.com
Contact Person Name
Weronika Kleczynska-Szpakiewicz
Site Name
Medicover Integrated Clinical Services Sp. z o.o. (Warsaw Wronia)
Department Name
MICS Centrum Medyczne Warszawa
Principal Investigator Name
Malgorzata Gryka-Marton
Principal Investigator Email
malgorzatagrykamarton@medycynakliniczna.pl
Contact Person Name
Malgorzata Gryka-Marton
Site Name
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Department Name
Klinika Reumatolgii i Ukladowych Chorob Tkanki Łacznej
Principal Investigator Name
Piotr Ignaczak
Principal Investigator Email
pmi@autograf.pl
Contact Person Name
Piotr Ignaczak
Contact Person Email
pmi@autograf.pl
Site Name
Lukmed 2 Sp. z o.o.
Department Name
ETG Siedlce
Principal Investigator Name
Tomasz Bocianowski
Principal Investigator Email
t.bocianowski@etg-network.com
Contact Person Name
Tomasz Bocianowski
Contact Person Email
t.bocianowski@etg-network.com
Site Name
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Department Name
Centrum Wsparcia Badan Klinicznych
Principal Investigator Name
Brygida Kwiatkowska
Principal Investigator Email
cwbk.brygidakwiatkowska@spartanska.pl
Contact Person Name
Brygida Kwiatkowska

Hungary

Earliest CTIS Part Ii Submission Date
04-06-2025
Latest Decision Or Authorization Date
03-07-2025
Processing Time Days
29
Number Of Sites
7
Number Of Participants
32

Sites

Site Name
University Of Szeged
Principal Investigator Name
Attila Balog
Principal Investigator Email
balog.attila@med.u-szeged.hu
Contact Person Name
Attila Balog
Contact Person Email
balog.attila@med.u-szeged.hu
Site Name
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Department Name
Internal medicine- immunology ambulance
Principal Investigator Name
János Kádár
Principal Investigator Email
drkadarj@t-online.hu
Contact Person Name
János Kádár
Contact Person Email
drkadarj@t-online.hu
Site Name
Semmelweis University
Department Name
Reumatológiai és Immunológiai Klinika
Principal Investigator Name
Nóra Anna Szabó
Principal Investigator Email
szabnora@yahoo.com
Contact Person Name
Nóra Anna Szabó
Contact Person Email
szabnora@yahoo.com
Site Name
Clinexpert Kft.
Principal Investigator Name
István Láng
Principal Investigator Email
prof.lang.istvan@clinexpert.hu
Contact Person Name
István Láng
Contact Person Email
prof.lang.istvan@clinexpert.hu
Site Name
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
Principal Investigator Name
Bernadette Rojkovich
Principal Investigator Email
dr.rojkovich.bernadette@gmail.com
Contact Person Name
Bernadette Rojkovich
Site Name
University Of Debrecen
Department Name
Clinic of Internal Medicine, Department of Clinical Immunology
Principal Investigator Name
Antónia Szántó
Principal Investigator Email
szantonia77@gmail.com
Contact Person Name
Antónia Szántó
Contact Person Email
szantonia77@gmail.com
Site Name
Vita Verum Medical Bt.
Principal Investigator Name
Tünde Varga
Principal Investigator Email
vargatundedr1@gmail.com
Contact Person Name
Tünde Varga
Contact Person Email
vargatundedr1@gmail.com

Netherlands

Earliest CTIS Part Ii Submission Date
09-01-2026
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
10
Number Of Sites
4
Number Of Participants
3

Sites

Site Name
Universitair Medisch Centrum Groningen
Department Name
Rheumatology and Clinical Immunology
Principal Investigator Name
Hendrika Bootsma
Principal Investigator Email
systeemziektenstudies@reuma.umcg.nl
Contact Person Name
Hendrika Bootsma
Site Name
Frisius MC
Department Name
Rheumatology
Principal Investigator Name
Reinhard Bos
Principal Investigator Email
r.bos@frisiusmc.nl
Contact Person Name
Reinhard Bos
Contact Person Email
r.bos@frisiusmc.nl
Site Name
Medisch Spectrum Twente
Department Name
Rheumatology
Principal Investigator Name
Harald Vonkeman
Principal Investigator Email
reumatologie@mst.nl
Contact Person Name
Harald Vonkeman
Contact Person Email
reumatologie@mst.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Rheumatology and Clinical Immunology
Principal Investigator Name
Ivette Essers
Principal Investigator Email
ivette.essers@mumc.nl
Contact Person Name
Ivette Essers
Contact Person Email
ivette.essers@mumc.nl

Norway

Earliest CTIS Part Ii Submission Date
05-12-2025
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
45
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Helse Stavanger HF
Department Name
Dept of Rheumatology
Principal Investigator Name
Jens Vikse
Principal Investigator Email
jens.vikse@sus.no
Contact Person Name
Jens Vikse
Contact Person Email
jens.vikse@sus.no
Site Name
Oslo Universitetssykehus HF
Department Name
Dept of Rheumatology
Principal Investigator Name
Oyvind Molberg
Principal Investigator Email
oyvind.molberg@medisin.uio.no
Contact Person Name
Oyvind Molberg
Contact Person Email
oyvind.molberg@medisin.uio.no

Czechia

Earliest CTIS Part Ii Submission Date
12-12-2025
Latest Decision Or Authorization Date
14-01-2026
Processing Time Days
33
Number Of Sites
7
Number Of Participants
7

Sites

Site Name
Revimex pro s.r.o.
Principal Investigator Name
Gabriela Stolarz
Principal Investigator Email
revimex@email.cz
Contact Person Name
Gabriela Stolarz
Contact Person Email
revimex@email.cz
Site Name
Artroscan s.r.o.
Principal Investigator Name
Ladislav Bortlik
Principal Investigator Email
bor-med@volny.cz
Contact Person Name
Ladislav Bortlik
Contact Person Email
bor-med@volny.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Revmatologicka ambulance
Principal Investigator Name
Zdenek Fojtik
Principal Investigator Email
fojtik.zdenek@fnbrno.cz
Contact Person Name
Zdenek Fojtik
Contact Person Email
fojtik.zdenek@fnbrno.cz
Site Name
Revmatologie s.r.o.
Principal Investigator Name
Petr Nemec
Principal Investigator Email
revmatologie.nemec@seznam.cz
Contact Person Name
Petr Nemec
Contact Person Email
revmatologie.nemec@seznam.cz
Site Name
MEDICAL PLUS Research s.r.o.
Principal Investigator Name
Eva Dokoupilova
Principal Investigator Email
evadokoupil@gmail.com
Contact Person Name
Eva Dokoupilova
Contact Person Email
evadokoupil@gmail.com
Site Name
MUDr. Zuzana Stejfova
Principal Investigator Name
Zuzana Stejfova
Principal Investigator Email
stejfova.zuzana@seznam.cz
Contact Person Name
Zuzana Stejfova
Contact Person Email
stejfova.zuzana@seznam.cz
Site Name
Other listed Czech site

Slovakia

Earliest CTIS Part Ii Submission Date
19-12-2025
Latest Decision Or Authorization Date
20-01-2026
Processing Time Days
32
Number Of Sites
7
Number Of Participants
7

Sites

Site Name
Reumex s.r.o.
Principal Investigator Name
Viola Husarova
Principal Investigator Email
reumexrecepty@gmail.com
Contact Person Name
Viola Husarova
Contact Person Email
reumexrecepty@gmail.com
Site Name
Artromac N.O.
Principal Investigator Name
Michaele Zarikova
Principal Investigator Email
m.zarikova@gmail.com
Contact Person Name
Michaele Zarikova
Contact Person Email
m.zarikova@gmail.com
Site Name
Narodny Ustav Reumatickych Chorob
Principal Investigator Name
Roman Stancik
Principal Investigator Email
roman.stancik@nurch.sk
Contact Person Name
Roman Stancik
Contact Person Email
roman.stancik@nurch.sk
Site Name
Thermium s.r.o.
Principal Investigator Name
Ivan Rybar
Principal Investigator Email
thermium@thermium.sk
Contact Person Name
Ivan Rybar
Contact Person Email
thermium@thermium.sk
Site Name
Medman s.r.o.
Principal Investigator Name
Viliam Manka
Principal Investigator Email
medmansro@gmail.com
Contact Person Name
Viliam Manka
Contact Person Email
medmansro@gmail.com
Site Name
Reumamed Poprad s.r.o.
Principal Investigator Name
Daniela Tkacova
Principal Investigator Email
reumapoprad@gmail.com
Contact Person Name
Daniela Tkacova
Contact Person Email
reumapoprad@gmail.com
Site Name
Other listed Slovakia site

Sponsor

Primary sponsor

Full Name
Janssen Cilag International
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Contract research organisations

Name
Labcorp Central Laboratory Services LP
Responsibilities
sponsorDuties code: 4
Name
Clario Medical Imaging Inc.
Responsibilities
ePRO and ClinROs
Name
4g Clinical LLC
Responsibilities
sponsorDuties code: 3

Third parties

  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clario Medical Imaging Inc.","duties_or_roles":"ePRO and ClinROs","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
JNJ-80202135
Active Substance
NIPOCALIMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS
Investigational Product Name
Placebo subcutaneous without Nipocalimab
Modality
Other

Related trials

Other published trials that may interest you.